Home NDC 30698-455-04 RALDESY
Product NDC 30698-455
Requested package NDC 30698-455-04
11-digit product format 306980455
Labeler code 30698
Product ID 30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAZODONE HYDROCHLORIDE ORAL
Dosage form SOLUTION
Route ORAL
Labeler Validus Pharmaceuticals LLC
Application NDA218637
Marketing category NDA
Marketing start 2024-11-26
Substance TRAZODONE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218637-001 RALDESY TRAZODONE HYDROCHLORIDE 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218637-001 RALDESY 10MG/ML SOLUTION / ORAL RLD, RS 2024-11-26 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218637-001 8133893 2029-03-13 Drug substance, Drug product 2024-12-04 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base RALDESY
Brand name suffix TM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6E8ZO8LRNM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856381 Internal RxNorm lookup 2699618 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30698-455-01 RALDESYTM 300 mL in 1 BOTTLE SOLUTION 300 4 30698-455-02 RALDESYTM 150 mL in 1 BOTTLE SOLUTION 150 4 30698-455-03 RALDESYTM 150 mL in 1 BOTTLE, GLASS SOLUTION 150 4 30698-455-04 RALDESYTM 300 mL in 1 BOTTLE, GLASS SOLUTION 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30698-455 RALDESY TM (TRAZODONE HYDROCHLORIDE ORAL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 3 Current NDC, 4 package rows 20250406_34708cc1-b0b2-4fd0-b9f3-7f008b457fc9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 30698-455-04 30698045504 300 mL in 1 BOTTLE, GLASS (30698-455-04) 300 ml 2024-11-26 No No Current